Tag: generic drug approval
Bioequivalence Explained: FDA Requirements to Prove Generic Drug Equivalence
Learn how the FDA proves generic drugs work just like brand-name versions using bioequivalence studies, Cmax, AUC, and the 80-125% rule. Understand what really makes generics safe and effective.
Deficiency Letters in Generic Drug Applications: Common FDA Findings and How to Avoid Them
Deficiency letters from the FDA are the most common reason generic drug applications fail. Learn the top 5 causes-dissolution issues, impurities, sameness problems, manufacturing flaws, and poor documentation-and how to avoid them for faster approval.